Home / Country Focus / France / Licensing Guidelines and Regulations

Licensing Guidelines and Regulations Posted 03/08/2012

First posted: 3 August 2012 

The French public health insurance system was implemented in 1945. It is divided into three main schemes:

  • The general scheme, which covers employees in the industry, business and services sectors, covers 85% of the French population. It is managed by the National Health Insurance Fund for Salaried Employees (Caisse Nationale d’Assurance Maladie des Travailleurs Salariés, CNAMTS).
  • The agricultural scheme, which covers farmers and farm employees (about 7% of the population covered), is managed by the Agricultural Mutual Insurance Fund (Mutualité Sociale Agricole, MSA).
  • The scheme for non-salaried and non-farming, self-employed workers (about 5% of the population covered), which covers craftspeople, retailers and independent professions, is managed by various organisations belonging to the National Insurance Fund for Self- employed Workers (Régime Social des Indépendants, RSI) [1].

The general health insurance scheme is funded mainly through social contributions (46%) and taxes (45%) [1].

A total of 93% of the population is also covered by complementary health insurance which covers the difference between co-payments and the full price [1].

Generics are defined in the public health code (Code de la Santé Publique, CSP) Art. L601-646 [1].

France has a high number of patent disputes between generic and originator companies. Between 2000 and 2007 there were 145 patent disputes, accounting for 10% of generics applications, from originator companies against marketing authorisations concerning the products of generic companies [2].

The average time for a generic drug to obtain marketing authorisation in France is more than 10 months, which is above the EU average of around seven months [3, 4]. The average time interval between marketing authorisation and patient access to medicines is also one of the longer periods among the EU countries with 67% of medicines being available within 289 days after receiving marketing approval [5].

The French Medicines Agency (Agence Française de Sécurité Sanitaire des Produits de Santé, AFSSAPS), created on 1 July 1998, is responsible for granting market authorisation. The AFSSAPS is also in charge of classification, vigilance and advertisement control [1].

A generic medicine can normally be marketed 10 years after the first authorisation of the reference drug and at the latest 15 years after the reference drug was placed on the market [6].

In 2004, three measures were introduced to increase growth of the generics market and reduce the effect of actions of innovator firms trying to delay entrance to the market of any new generics [1]:p 

  • Application of the European definition of a generic drug: the definition of an active molecule has been extended to all molecules derived from it (esters, sales, isomers, etc.).
  • Market authorisation for a generic can now be granted prior to expiry of the patent of the original product. Thus, the commercialisation of generics can start as soon as the original product enters the off-patent market.
  • The additional 10-year data protection, automatically granted for line extensions of existing products when dosage and/or pharmaceutical form differ, no longer applies [7].

The normal way to obtain market authorisation is under the European Commission Directive 2004/27. The usual time frame for this process is 210 days. A simplified procedure exists for generics by proving the bioequivalence of the pharmaceutical with the original product. The AFSSAPS has become responsible only for the evaluation of bioequivalence in the course of the market authorisation procedure [1].

References

1.  Van Ganse E, Chamba G, Bruet G, Becquart V, Stamm C, Lopes S, Marty C. Pharma profile France. Pharmaceutical Pricing and Reimbursement Information (PPRI). 2008 Jul. Available from: http://ppri.oebig.at/Downloads/Results/France_PPRI_2008.pdf

2.  European Commission. DG Competition Staff Working Paper. Pharmaceutical Sector Inquiry Preliminary Report. 2008 Nov 28. Available from: ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf

3.  Glowicka E, Lorincz S, Pesaresi E, Sauri Romero L, Verouden V. Generic entry in prescription medicines in the EU: main characteristics, determinants and effects. 2009 Jul 8.

4.  Bongers F, Carradinha H. European Generic medicines Association (EGA) Health Economics Committee. How to increase patient access to generic medicines in European healthcare systems. 2009 Jun.

5.  European Federation of Pharmaceutical Industries and Associations (EFPIA). The pharmaceutical industry in figures. Edition 2010, updated 2011.

6.  Mutualité Française. Les Études de la Mutualité Française: Bilan de 25 ans de politique du médicament générique: propositions pour une politique plus ambitieuse. 2008 Oct. French.

7.  Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Surveying, assessing and analysing the pharmaceutical sector in the 25 EU Member States. 2006 Jul.

Useful information sources
EMA, Committee for Proprietary Medicinal Products (CPMP). Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) [monograph on the Internet]. London, UK, EMA; 2008 Jul 24 [cited 2012 Jun 10]. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003011.pdf

EMA, Committee for Medicinal Products for Human Use (CHMP). EMEA Procedural Advice for Users of the Centralised Procedure for Generic/Hybrid Applications (EMEA/CHMP/ 225411/2006) [monograph on the Internet]. London, UK, EMA; 2008 Jul 2 [cited 2012 Jun 10]. Available from: www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004018.pdf

EMA, Committee for Proprietary Medicinal Products (CPMP). Note for guidance on modified release oral and trans-dermal dosage forms: section II (pharmacokinetic and clinical evaluation) (CPMP/EWP/280/96) [monograph on the Internet]. London, UK, EMA; 1999 [cited 2012 Jun 10]. Available from: www.ema.europa.eu/pdfs/human/ewp/028096en.pdf

EMA, Committee for Proprietary Medicinal Products (CPMP). Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95) [monograph on the Internet]. London, UK, EMA; 1995 [cited 2012 Jun 10]. Available from: www.ema.europa.eu/pdfs/human/ewp/023995en.pdf

Comments (0)

Generics News Research General

more

Biosimilars News Research General

more